Biocompatibility testing for medical devices

Biocompatibility assessment by ISO 10993 is a crucial step in bringing medical devices to the market. We offer all the required tests for assessing biocompatibility by EU and FDA regulations, and our experts are always happy to answer any questions regarding the process.
Biocompatibility
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Our selection of ISO 10993 testing options

Measurlabs offers an extensive range of accredited and GLP-certified biocompatibility tests according to the ISO 10993 standard family. Almost all new medical devices regardless of body contact site or duration require the following tests for market approval:

We also offer additional tests for evaluating further biocompatibility endpoints, such as hemocompatibility (ISO 10993-4), pyrogenicity (ISO 10993-11), and genotoxicity (ISO 10993-3). Both in vitro and in vivo testing options are available for many of the endpoints.

Due to the variation in medical device composition and intended use – both of which affect the testing requirements – the appropriate testing procedure is always agreed upon on a case-by-case basis. Do not hesitate to contact our experts for more information and to request a quote for your device.

Elina Tenhunen

Questions?

Medical device testing expert Elina Tenhunen is happy to help.

+358 44 021 4168

Large service selection, commitment to quality & exceptional customer service

Our global network of partner laboratories allows us to offer an exceptionally large variety of medical device tests in one place. In addition to ISO 10993 biocompatibility assessments, our service selection includes medical device packaging validation, bacterial endotoxin testing, bioburden and sterility evaluations, and mechanical testing.

The medical device tests we offer are performed in ISO 17025-accredited and GLP-certified laboratories. This ensures that you get the test reports in a format that can be submitted to officials for FDA premarket submissions and EU MDR conformity assessments.

You will also get all the necessary support from our highly qualified testing experts throughout the process. With their help, you can reduce the time spent on contemplating which biocompatibility tests to perform and with which methods, thus freeing time for other important projects.

Why choose Measurlabs?

Widest range of testing methods – get all your tests done in the same place.

Best laboratories – for every test, we have sourced the best lab for that particular method, which means that you get the most accurate results and the best price.

Personal service – get help from method experts if you are unsure about standards, your testing needs or sample suitability.

Get a quote

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Answering the following questions helps us prepare an offer for you faster:

  • What is the intended use of your medical device? How does it contact the body, and how long is the contact duration?

  • Have you already determined which tests should be conducted on your device?

  • Do you need the tests for R&D purposes or for submission to officials?

Have questions or need help? Email us at or call +358 50 336 6128.